Manufacturers of pharmaceutical products are often required by federal regulations to provide substantial amounts of printed warnings and other information with the pharmaceutical products. For many categories of pharmaceutical products, it is not uncommon for required information and conventional formatting to require as much as 500 square inches of printed surface. Because unfolded printed sheets are often difficult to package with the pharmaceutical product and tend to be destroyed and separated from the product during packaging and handling or by the consumer, the industry generally employs folded leaflets. The required information is printed on a sheet and the sheet is thereafter folded along one or more parallel and/or transverse fold lines. In this way, a large amount of printed text is provided on a relatively compact label. Also, much of the printed text is not exposed until the leaflet is unfolded so that it is protected during shipping, handling and the like.
Many pharmaceutical products are not packaged by the manufacturer for direct distribution to the end user. Rather, a pharmaceutical product may be packaged for distribution to a pharmacist or physician who redistributes the product to patients. In some cases, the product is packaged in a bulk container from which the pharmacist or physician takes smaller quantities which he or she individually re-packages. It is often necessary to provide the pharmacist with a number of informational leaflets. Even where the pharmaceutical product is individually prepackaged, it may be more cost-effective and efficient to simply provide the pharmacist or physician with a prescribed number of leaflets for distribution with the individual packages, rather than requiring that the manufacturer match the leaflets with the individual packages.
For the foregoing reasons, pharmaceutical product manufacturers often package a prescribed number of informational leaflets with a package of the product which is intended for distribution to a pharmacist or physician. Both to facilitate placement of the leaflets into the package and handling by the pharmacist or physician, it is desirable that the plurality of leaflets be grouped and held together. However, the leaflets must not be held together in such a manner as to prevent their ultimate separation for individual distribution with the product to patients.
To meet the foregoing needs, rubber bands have been used to hold together stacks of leaflets for placement in packaging. However, this technique suffers from a number of significant drawbacks. Placement of the rubber band about the stack of leaflets is time consuming and labor intensive and, as a result, tends to be cost prohibitive. The rubber bands interfere with or prevent automatic dispensing of the banded leaflets from a conventional magazine because the rubber bands tend to bind in the magazine. Also, the rubber bands may obfuscate bar codes or other indicia on the exposed surfaces of the leaflets which may be scanned during the packaging and handling processes.
It has also been proposed to provide a stack of folded leaflets secured together by adhesively coating opposite end edges of the leaflets. However, to Applicants' knowledge, no suitable method has been proposed for mass producing such assemblies of leaflets. It is important that the adhesive be properly chosen and applied so that the leaflets are neither insufficiently nor overly adhered to one another. Further, in order for the method to be commercially feasible, the method must be cost-effective and convenient. Further, the method should be relatively mess-free and involve little specialized equipment.